EN    EN EN 
SANCO/12566/2010 Rev. 1 (POOL/E4/2010/12566/12566R1-EN.doc)  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2011) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion of certain health claims made on foods 
and referring to the reduction of disease risk 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion of certain health claims made on foods 
and referring to the reduction of disease risk  
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the 
Council of 20 December 2006 on nutrition and health claims made on foods
1, and in 
particular Article 17(3) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/ 2006 health claims made on foods are 
prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims. 
(2) Regulation (EC) No 1924/2006 al so provides that applications for authorisations of 
health claims may be submitted by food business operators to the national competent 
authority of a Member State. The national competent authority is to forward valid 
applications to the Eu ropean Food Safety Authority (EFSA ), hereinafter referred to as 
'the Authority'. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Comm ission thereof, and to deli ver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authorisa tion of health claims taking into account 
the opinion delivered by the Authority. 
(5) The three opinions referred to in this Re gulation are related to applications for 
reduction of disease risk claims, as referred to in Article 14(1)(a) of Regulation (EC) 
No 1924/2006.  
(6) Following an application from 
Wrigley GmbH , submitted pursuant to Article 14(1)(a) 
of Regulation (EC) No 1924/2006, the Authority  was required to deliver an opinion on 
a health claim related to the effects of sugar-free chewing gum and reduction of tooth 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
EN 3   EN demineralisation (Question No EFSA-Q-2010-00119)2. The claim proposed by the 
applicant was worded as follows: "Chewing of sugar-free chewi ng gum remineralises 
tooth enamel which reduces th e risk of dental caries". 
(7) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 1 October 2010 that a cause and effect 
relationship has been established between the consumption of s ugar-free chewing gum 
and the claimed effect. Accordingly, a hea lth claim reflecting this conclusion should 
be considered as complying with the re quirements of Regulation (EC) No 1924/2006, 
and it should be included in the Union list of permitted claims.  
(8) Following an application from Wrigley GmbH , submitted pursuant to Article 14(1)(a) 
of Regulation (EC) No 1924/2006, the Authority  was required to deliver an opinion on 
a health claim related to the effects of sugar-free chewing gum and neutralisation of 
plaque acids which reduces the risk of dental caries (Question No EFSA-Q-2010-
00120)3. The claim proposed by the applicant was worded as follows: "Chewing of 
sugar-free chewing gum neutralises plaque acids which reduces the risk of dental 
caries". 
(9) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 1 October 2010 that a cause and effect 
relationship has been established between the consumption of s ugar-free chewing gum 
and the claimed effect. Accordingly, a hea lth claim reflecting this conclusion should 
be considered as complying with the re quirements of Regulation (EC) No 1924/2006, 
and it should be included in the Union list of permitted claims.  
(10) Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of 
authorising a health claim should include certain particulars.  Accordingly, those 
particulars should be set out in the Annex I to  this Regulation as regards the authorised 
claims and include, as the case may be, the revised wording of the claims, specific 
conditions of use of the claims, and, where a pplicable, conditions or restrictions of use 
of the food and/or an additional statement or  warning, in accordance with the rules laid 
down in Regulation (EC) No 1924/2006 and in line  with the opinions of the Authority. 
(11) One of the objectives of Regulation (EC) No  1924/2006 is to ensure that health claims 
are truthful, clear and reliable and useful  to the consumer, and that wording and 
presentation are taken into account in that respect. Ther efore, where the wording of 
claims has the same meaning for consumers as  that of an authorised health claim, 
because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and healt h, they should be subject to the same 
conditions of use, as indicated in Annex I.  
(12) Following an application from GP International Holding B.V., submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects of OPC Plus
 on the reduction 
of the risk of chronic venous insufficiency (Question No EFSA-Q-2009-00751)4. The 
claim proposed by the applicant was worded as  follows: "OPC Plus has been shown to 
                                                 
2 The EFSA Journal 2010;8(10):1775. 
3 The EFSA Journal 2010;8(10):1776. 
4 The EFSA Journal 2010 ; 8(7):1691.  
EN 4   EN increase the microcirculation and may ther efore reduce the risk of chronic venous 
insufficiency".  
(13) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 7 September 2010 that a cause and effect 
relationship had not been established between the consumption of OPC Plus and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(14) The comments from the applicants and the members of the public received by the 
Commission pursuant to Article 16(6) of  Regulation (EC) No  1924/2006 have been 
considered when setting the measur es provided for in this Regulation. 
(15) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims listed in Annex I to this Regulation may be made on foods on the 
European Union market in compliance with  the conditions laid down in that Annex. 
2. The health claims referred to in paragr aph 1 shall be included in the Union list of 
permitted claims as provided for in Artic le 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
The health claim listed in Annex II to this Regula tion shall not be included in the Union list of 
permitted claims as provided for in Artic le 14(1) of Regulation (EC) No 1924/2006. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN ANNEX I  
Permitted health claims 
Application 
– Relevant 
provisions of 
Regulation 
(EC) No 
1924/2006 Applicant – 
Address Nutrient, 
substance, 
food or food 
category Claim Conditions of use of the claim Conditions 
and/or 
restrictions 
of use of the 
food and/or 
additional 
statement or 
warning EFSA 
opinion 
reference 
Article 
14(1)(a) health claim referring to reduction of 
disease risk Wrigley GmbH, 
Scientific and Regulatory Affairs EMEAI, Biberger str. 18, D-82008, Unterhaching, 
Germany  Sugar-free 
chewing gum Sugar-free chewing gum helps 
reduce tooth demineralisation. Tooth demineralisation is a risk factor in the development 
of dental caries. Information shall be given to the 
consumer that the beneficial effect is obtained with chewing of 2-3 g of sugar-free chewing gum for 20 minutes, at least three times per 
day after meals.
  Q-2010-
00119 
Article 
14(1)(a) health claim referring to reduction of 
disease risk Wrigley GmbH, 
Scientific and Regulatory Affairs EMEAI, Biberger str. 18, D-82008, Unterhaching, 
Germany  Sugar-free 
chewing gum Sugar-free chewing gum helps 
neutralise plaque acids. Plaque acids are a risk factor in the 
development of dental caries. Information shall be given to the 
consumer that the beneficial effect is obtained with chewing of 2-3 g of sugar-free chewing gum for 20 minutes, at least three times per 
day after meals.
  Q-2010-
00120 
  
EN 6   EN ANNEX II  
Rejected health claim 
Application – Relevant provisions 
of Regulation (EC) No 1924/2006 Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(a) health claim 
referring to a reduction of a disease 
risk OPC Plus  OPC Plus has been shown to increase the 
microcirculation and may therefore 
reduce the risk of chronic venous 
insufficiency Q-2009-00751